This invention relates to a device for expediting the non-invasive infusion of a fluid into the uterine cavity. More specifically, the device provides a single step procedure for infusing fluid through a single catheter and sealing the uterus with an adjustable seal in order to perform therapeutic and/or diagnostic procedures.
A number of conditions require the non-invasive entry into the uterine cavity, for both therapeutic and diagnostic purposes. Such access is provided through the canal of the uterocervix, transvaginally for diagnostic purposes. Contrast media and/or image enhancing media may be injected into the cervical canal and radiography, sonohysterography may be carried out, to, e.g. establish the outline of the uterine cavity and/or patency of the Fallopian tubes, to diagnose or determine the development of polyps and/or submucous myomas.
Non-invasive access to the Fallopian tubes is also utilized for the purposes of artificial insemination as well as diagnostic reasons. Typically, this procedure, which has been shown to be at least twice as effective as in vitro fertilization, involves harvesting the eggs and injecting a mixture of sperm and egg into the Fallopian tubes. While this procedure can be carried out under hysteroscopic, radiographic or ultrasonographic control, the common denominator of all of these procedures is access through the cervical canal and insertion of multiple catheters into the tubes. Another possible use of selective tubal catheterization is to inject compositions for the purpose of reversible sterilization.
A number of devices have been designed for the purposes discussed above, however, most of them involve multiple catheters and thus generally requiring multiple procedural steps as well as utilizing sealing devices, e.g., balloons, which may increase the discomfort to the patient as well as requiring longer time for carrying out the procedure.
Other alternative diagnostic procedures for such conditions as polyps or myomas are generally surgical procedures, such as hysteroscopy; but involve a greater risk to the patient, are not always definitive, as well as requiring much longer time to carry out the procedure for a less definitive diagnosis, and a greater expense.
Thus, a device is needed for infusing or instilling a fluid, e.g., an image enhancing fluid such as saline, for instillation sonohysterography or other similar diagnostic and/or therapeutic procedures. Also, the device requires a seal for the cervical opening that may be adjustable as well as avoiding the pain and cramping that may arise by the use of an inflation membrane, e.g., a balloon.
In accordance with the present invention, a device for instilling, i.e., infusing, a fluid into the uterine cavity for various diagnostic and/or therapeutic purposes is provided.
Further in accordance with the present invention, a method is provided for infusing a fluid into the uterus for diagnostic and/or therapeutic procedures.
Still further in accordance with the present invention, a device is provided for a non-invasive infusion of a fluid in the uterine cavity wherein the device comprises an elongated tubular body having proximal and distal ends;
a slidable cervical seal located on the tubular body and slidable along the entire length of the tubular body wherein the seal engages the opening of the cervix and at least partially seals the cervix opening from the discharge of fluid contained within the uterus;
an opening in the distal end of the tubular body to allow the discharge of fluid and the proximal end adapted to deliver fluid to the uterus thru the opening in the distal end.
Still further in accordance with the present invention, a device is provided for the non-invasive infusion of fluid into the uterus wherein the device comprises an elongated tubular body having a slidable cervical seal positioned on the tubular body and the cervical seal has a conical shape having a neck at the distal end of the seal for easily engaging the cervical opening.
Still further in accordance with the present invention, a specific method is provided for detecting polyps or tumors within the uterus and for determining or monitoring endometrial thickness by using the device of the present invention for saline instillation sonohysterography.
Still further in accordance with the present invention, a method and device is provided for instilling fluid within the uterus while avoiding discomfort and cramping to the patient by providing a device wherein the cervical seal of the device will allow liquid to leak around the seal in the event the fluid pressure within the uterus becomes too high.
To the accomplishment of the foregoing and related ends, the invention, then, comprises the features herein after fully described and particularly pointed out in the claims. The following description and the annexed drawings setforth, detail certain illustrative embodiments of the invention. These embodiments are indicative, however, of but a few of the various ways in which the principles of the invention mentioned may be employed. Other objects, advantages and novel features of the invention will become apparent from the following detailed description of the invention when considered in conjunction with the drawings.